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Welcome OnTrak with FSMA: A Webinar Series
Hosted by: ReposiTrak®
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FSMA Finalizes Sanitary Transportation: Impact of Key Changes
Hilary Thesmar, PhD, RD, CFS VP Food Safety Programs, Food Marketing Institute
Jorge Hernandez Chief Food Safety Officer Wholesome International
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FMI Antitrust Statement FMI believes strongly in competition. Our antitrust laws are the rules under which our competitive system operates. It is FMI’s policy to comply in all respects with the antitrust laws.
Association meetings or workshops by their very nature bring competitors together. It is expected that all member representatives involved in FMI activities, as well as FMI consultants and other participants, will be sensitive to the legal issues and act in compliance with applicable antitrust and competition laws both at FMI meetings and FMI-sponsored events.
Accordingly, it is necessary to avoid discussions of sensitive topics that can create antitrust concerns. Agreements to fix prices, allocate markets, engage in product boycotts and to refuse to deal with third parties are illegal under the antitrust laws. At any association meeting discussions of prices (including elements of prices such as allowances and credit terms), quality ratings of suppliers, and discussions that may cause a competitor to cease purchasing from a particular supplier, or selling to a particular customer, should be avoided. Also, there should be no discussion that might be interpreted as a dividing up of territories.
An antitrust violation does not require proof of a formal agreement. A discussion of a sensitive topic, such as price, followed by action by those involved or present at the discussion is enough to show a price fixing conspiracy. As a result, those attending an association-sponsored meeting should remember the importance of avoiding not only unlawful activities, but even the appearance of unlawful activity.
As a practical matter violations of these rules can have serious consequences for a company and its employees. Antitrust investigations and litigation are lengthy, complex and disruptive. The Sherman Act is a criminal statute, and may even result in penalties punishable by steep fines and imprisonment. The Justice Department, state attorneys general and any person or company injured by a violation of the antitrust laws may bring an action for three times the amount of the damages, plus attorney’s fees.
If you have any questions or concerns at this meeting, please bring them to the attention of FMI staff.
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FDA Authorities Now in Effect
• Increased Inspection Authority – Depends on appropriations
• Increased Records Access
• Mandatory Recall Authority
• Import Certification Authority
• Fees for Re-inspection
• Administration Detention
• Facility Registration and Suspension of Registration
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Review of the 7 Major Rules Seven Major FSMA
Regulations Publication Date or
Expected Date Expected Compliance
Deadline**
1. Preventive Controls – Human food
September 17, 2015 September 17, 2016
2. Preventive Controls – Animal food
September 17, 2015 September 17, 2016 cGMP September 19, 2017 PC
3. Produce Safety November 27, 2015 November 27, 2017
4. Foreign Supplier Verification Program
November 27, 2015 May 31 , 2017
5. Accreditation of Third Party Auditors
November 27, 2015 May 31, 2017
6. Sanitary Transportation April 6, 2016 April 6, 2017
7. Food Defense May 31, 2016 May 31, 2017 ?
** Compliance deadlines depend on several variables so check the rules for details
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FSMA Compliance at a Glance
Produce Grower/ Farm
Manufacturing or Processing
Any facility who Imports (retail,
wholesale, production)
Retail Distribution Center or
Warehouse
Transportation: Shippers, Loaders, Carriers, Receivers
Preventive Control Plan
Produce Safety
Foreign Supplier Verification
Sanitary Transportation
Food Defense
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SANITARY TRANSPORTATION Impact
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Who has to comply?
• Shippers
• Loaders
• Receivers
• Carriers
Engaged in transportation operations of food
Applies to intrastate and interstate transportation
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Details on the Final Rule
Sanitary Transportation of Human and Animal Food; Final Rule
Published in the Federal Register on April 6, 2016, Vol. 81, No 66, pages 20092-20170
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Types of Transportation
• Motor and Rail
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Scope Applies to: • Temperature controlled for
safety (TCS) Foods
• Food not completely enclosed by a container
• Animal food (includes pet, animal feed, raw materials and ingredients)
Exempt: • Foods regulated exclusively by
USDA • Food that is completely enclosed
by a container that is not TCS • Compressed food gases • Food contact substances as
defined in section 409(h)(6) of the FDCA
• Human food byproducts for use as animal food w/o further processing
• Live food animals except molluscan shellfish
All details are in the definitions section of the regulation – §1.904
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Definitions
• Shipper – a person (manufacturer or freight broker) who arranges for the transportation of food in the US by a carrier or multiple carriers sequentially
• Carrier – person who physically moves food by rail or motor vehicle in commerce within the US. Does not include any person who transports food while operating as a parcel delivery service.
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Definitions
• Loader – person that loads food onto a motor or rail vehicle during transportation operations
• Receiver – any person who receives food at a point in the US after transportation, whether or not that person represents the final point of receipt for the food
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Intent of Rule
• FDA was required to issue regulations for shippers and carriers by motor and rail to use sanitary transportation processes to avoid creating food safety risks
• History of the regulation goes back to 2005 with the FDA and 1990 with Sanitary Transportation of Food Act (1990) assigned to DOT
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What is required?
• Vehicles and equipment must be cleanable and suitable to prevent food from becoming unsafe during transportation ops
– Maintained in sanitary condition
– Designed, maintained and equipped to provide adequate temperature control
– Store in a manner to prevent pests
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Vehicle Operations
• Rules apply to all parties and roles might be combined
• Responsibilities may be reassigned through written agreements and contracts
– Subject to records requirements
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Vehicle Operations (continued)
• Goal is to prevent food from becoming unsafe during transportation (examples)
– Prevent cross contamination of raw foods and non-foods by segregation, isolation, and packaging
– Handwashing to protect food in bulk vehicles or open containers
– Temperature control of TCS products
– Conditions depend on type of food – animal feed, pet food, human food and product stage
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Intra-Company Shipments • “Common integrated written procedures” may be
used for shippers, receivers, loaders and carriers under the ownership or operational control of a single legal entity.
– This applies to the sections on the requirements for shippers, receivers and carriers.
– Written procedures are subject to the records requirements
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Additional Provision
• Requirement to stop sale or distribution of food if shipper, loader, receiver or carrier becomes aware of “of an indication of a possible material failure of temperature control or other conditions that may render the food unsafe during transportation” – Take appropriate action
– Communicate with other parties
– Determination by a qualified individual
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Shippers
• Specify in writing to the carrier and if appropriate the loader, the conditions for the sanitary specifications of the vehicle and equipment. – This includes design specs, cleaning procedures,
sanitary conditions, temperature requirements including pre-cooling
– Can be a one time written notification if the information does not change
– Subject to records requirements
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Loaders
• Determine specific requirements for containers not completely enclosed to avoid contamination and evaluate condition (pests)
• Verify temperature requirements and condition of refrigerated storage
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Receivers
• Upon receiving TCS food, the receiver must “take steps to adequately assess that the food was not subjected to significant temperature abuse, such as determining the food’s temperature, the ambient temperature of the vehicle and its temperature setting, and conducting a sensory inspection, e.g., for off-odors.”
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Carriers
• Depending on the written agreement*, the carrier is responsible for: – Equipment meets specs to prevent the food from
becoming unsafe during transportation – If requested provide operating temperature and
demonstrate temperature conditions were maintained (by agreed upon means)
– Identify previous cargo for bulk containers, and information on most recent cleaning
– Written procedures on sanitary condition of vehicles and equipment, transportation control, and bulk vehicle requirements
*only applies when a written agreement is in place between shipper and carrier identifying the carrier as responsible for these activities
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Training
• Carrier must provide “adequate” training to personnel engaged in transportation operations – Potential food safety problems that can occur
– Basic sanitary transportation practices
– Responsibilities of the carrier
• Training required upon hiring and as needed
• Training records – date, type of training, and name of person trained
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Records • Shippers and Carriers
– Specific records requirements – Written agreements
• Intra-Company (single legal entity) – written procedures
• All records must be kept for 12 months beyond when the procedures are in use
• All records are required to be available to an duly authorized individual promptly upon oral or written request
• Carrier’s written procedures must be onsite but offsite storage is permitted for all other records if accessible in 24 hours.
• Electronic records are onsite if accessible onsite
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Waivers
• PMO – Transportation of Grade A milk and milk products
• Retail Stores – As receiver (facility is under jurisdiction of the Food
Code)
– Direct to consumer transportation
FDA is planning to issue a final rule on waivers
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Compliance Dates
• One year compliance date
– April 6, 2017
• Small Businesses
– April 6, 2018
• Non-motor carriers <500 FTE
• Motor carriers <$27.5 million in annual receipts
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Help from FDA?
• FDA Technical Assistance Network (TAN) – http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm459719.htm
• Stated an online training course is in development
• Stated a guidance document is in development
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SUMMARY
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Key Considerations for Sanitary Transportation
• Applies to shippers, carriers, loaders and receivers
• Covers food transported Interstate as well as Intrastate
• Valid for human or animal food shipped via rail or road
• Focuses on temperature control and avoiding contamination of products
• All records must be kept for 12 months beyond when the procedures are in use
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Impact: Sanitary Transportation
• Retailers/Wholesalers
– Communication with carriers
– Avoiding contaminating product
– Increased procedures and records
• Manufacturers
– Can perform any role in transportation
– Avoiding contaminating product
– Increased procedures and records
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Sanitary Transportation: Required Records
• Key difference – Records must be kept 12 months beyond when the procedures are in use
• Written agreements between parties
• Written standard operating procedures
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Sanitary Transportation: Your To-do List
Task Retail DC Wholesaler Manufacturer
Identify your role in transportation a a a
Put appropriate procedures in place a a a
Put appropriate training in place a a a
Put recordkeeping in place a a
Do these apply? Yes, if you pack, ship, load, carry or receive food. See rule exemptions for details.
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Thank You!
• Interest in food safety
– Compliance with FSMA requirements
– Preventive risk management
• ReposiTrak supporting SQF user experience
– Easier registration
– Faster audit results
• Have asked ReposiTrak to go deeper into food safety
– Food Safety Plan management
– Quality assurance
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For Help
• FDA Technical Assistance Network
– http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm459719.htm
• FDA FSMA Email updates
– https://public.govdelivery.com/accounts/USFDA/subscriber/new?topic_id=USFDA_206
• ReposiTrak
– http://repositrak.com/
Industry Standard Food Safety Platform
Two Components Co-founders
Compliance Management
Track & Trace
1-Stop System for All Compliance Records
Supplier & corporate records
Dashboards and automated, proactive exception-based alerts
Incredibly flexible
– Choose/create supplier classifications
– Customize document requirements
A rapidly growing community
For your entire supply chain
Our Active Approach? A Dedicated Team
We provide a dedicated staff
We clean AND build your supplier contact list
We reach out to every supplier and follow up until enrollment is complete
We ACTIVELY follow up with suppliers to correct non-compliance
70% Average decline in Non-Compliance among new users
on ReposiTrak
Utilizing ReposiTrak is as Easy as 1 – 2 – 3
Three main activities in ReposiTrak
1) Invite suppliers to enroll in ReposiTrak
2) Monitor overall compliance and enrollment stats
3) Manage non-compliance issues by supplier
39 Trusted Brand Protection
You Supplier
Supplier
Supplier
Supplier
Supplier
Invite New Vendors to Enroll in ReposiTrak
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Enter FOUR pieces of information:
Then send an invitation:
The Invitation Packet Includes…
A vendor letter, signed by you
A link to a video webisode explaining: – Your initiative
– FSMA requirements and tort risk
– Why ReposiTrak?
How to contact us
A link to enroll online
41 Trusted Brand Protection
Check on the Status of your Suppliers
Trusted Brand Protection 42
Tracks the progress of your supplier enrollment
Compliance Center dashboard shows the compliance status for your overall program and by supplier
Two Ways to View Non-Compliance Issues
1. View by Supplier
or
2. View by Document
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Just select the compliance status of interest: • Missing • Expired • Specs Not Met • All Exceptions
Provide Data to Your Downstream Customer
As a supplier, here’s how you will support a customer using ReposiTrak
1) Enroll servicing facilities
2) Upload required documents
3) Address non-compliance issues & monitor overall status
44 Trusted Brand Protection
Customer YOU
Supplier
Supplier
Supplier
Supplier
Maintain Updated Facility Information
Enter your company and contact information
Trusted Brand Protection 45
Configurable, partner-specific profile selections drive future activities and requirements
• Billing type, e.g. warehouse billing or central (DSD) billing
Upload Any Required Documents
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Add or Update the specified document To Become Compliant.
If the Status is Missing, add it. If it’s Expired or if the Specs
not met, update it…
Selecting “Become Compliant” kicks off a workflow process
Check on Your Compliance
Trusted Brand Protection
Quick view to your overall compliance rating
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Message Center provides area for updated requests
Input Receiving & Inspection Information
48 Trusted Brand Protection
Each record can be uploaded or transmitted to meet Sanitary Transportation recordkeeping requirements
Two flexible entry options:
1. Upload onscreen 2. Send digitally
Questions? Our ReposiTrak Team is Here to Help
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Christina Romas Sr. Vice President
Joe Meherg Vice President
Brad DeFrank Inside Sales Mgr. & Acct. Executive [email protected]
Leigh Feitelson Bus. Development Executive
Our contact us at www.repositrak.com or 888-327-6187
Randy Fields Chairman & CEO
Trusted Brand Protection
